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Olympus Medical Systems and a former senior executive plead guilty to failing to file required adverse event reports involving its...[ Price : $8.95]
FDA warns Indias Skylark CMC over its refusal to permit agency inspectors to enter manufacturing areas and refusal to provide requ...[ Price : $8.95]
Federal Register notice: FDA announces a 5/21 public meeting entitled FDAs Proposed Current Good Manufacturing Practice Policies f...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Current Good Manufacturing Practice Guidance for H...[ Price : $8.95]
FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agencys Biosimilars Action Plan.[ Price : $8.95]
Former FDAer Peter Lurie and journalism professor Charles Seife sue HHS, FDA, and NIH to overturn a final rule allowing some drug ...[ Price : $8.95]
FDA issues a draft guidance on the evidentiary framework it recommends for biomarker qualification under the 21st Century Cures Ac...[ Price : $8.95]
CDER issues a MAPP on procedures for integrated quality assessment of products containing drug substances composed of amino acid p...